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1069715

Beutlich Pharmaceuticals LLC — FEI 1413399

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
October 24, 2018
Fiscal Year
2019
Product Type
Devices
Project Area
Compliance: Devices
Location
Bunnell, FL (United States)

Facility

Other inspections at this facility

  • 1279681 (VAI Wed Aug 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 991891 (NAI Fri Nov 04 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 946582 (NAI Thu Oct 29 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 773041 (NAI Fri Mar 30 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 716447 (VAI Tue Feb 22 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
237121 CFR 820.30(a)Design control - no procedures
367821 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate